Afatinib for Cancer

Phase 2

Waitlist Available

Led By Philippe L Bedard

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have =< grade 1 diarrhea at baseline

In-frame insertions in exon 20 will be considered an activating mutation

Must not have

Patients must not have had prior treatment with any of the following tyrosine kinase inhibitors (TKIs), which have known activity against HER2 kinase

Patients with a history of interstitial lung disease will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effects of afatinib in patients with cancer that has HER2 mutations. Afatinib may stop cancer cell growth by blocking the HER2 receptor. Researchers hope to learn if afatinib will shrink or stop the growth of this type of cancer.

Who is the study for?

This trial is for cancer patients with specific HER2 genetic changes. They must have normal heart function, controlled diarrhea, and adequate kidney function. People with hypersensitivity to afatinib, lung disease history, or previous treatment with certain tyrosine kinase inhibitors are excluded.

What is being tested?

The trial tests Afatinib Dimaleate's effectiveness on cancers with HER2 mutations. It aims to see if this drug can shrink the tumors or halt their growth by blocking a protein essential for cancer cell development.

What are the potential side effects?

Afatinib may cause side effects such as diarrhea and skin reactions. Since it targets specific proteins in cancer cells, there might also be risks of abnormal liver tests, breathing problems, and potential heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I currently have mild or no diarrhea.

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My cancer has a specific genetic change in exon 20.

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My recent ECG showed no significant heart issues.

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My tumor has an activating HER2 mutation.

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My heart's pumping ability is within the normal range according to recent tests.

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My kidney function is good, meeting the trial's specific criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken any medication known to target HER2.

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I have never had interstitial lung disease.

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I do not have non-small cell lung cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration for reporting.